Protein formulations, which are free of stabilizing proteins are known in the art. WO 2006/020208 relates to pharmaceutical compositions comprising Botulinum toxin and a non-proteinaceous stabilizing agent, which retains the activity of the Botulinum toxin in an aqueous solution.
WO 2006/005910 relates to solid or liquid pharmaceutical compositions comprising Botulinum toxin complex or high purity Botulinum toxin and a surfactant. A maximum of six months stability at 23° C. to 27° C. is reported therein.
WO 2007/041664 relates to a pharmaceutical composition comprising a Botulinum toxin and a polyvinylpyrollidone (PVP) and optionally a disaccharide.
WO 2004/006954 relates to a pharmaceutical composition comprising a stabilized Botulinum toxin and at least one enhancing agent for facilitating transdermal delivery of the Botulinum toxin into a human patient by enhancing the permeability of the patient's skin.
WO 01/58472 discloses a pharmaceutical composition suitable for injection into a human patient, comprising a Botulinum toxin and a polysaccharide. It also discloses a pharmaceutical composition comprising a neurotoxin and hydroxyethyl starch.
WO 2006/079722 relates to the use of liquid compositions for implementing the method of freeze-drying proteins, to stabilize said proteins, said compositions comprising; a filler agent having a collapse temperature between −18° C. and 0° C., a stabilizer, a buffer solution, and, as the case may be, a nonionic surfactant.
European application 09005470.1-1219 also relates to stable compositions free of HSA.
US 2007/122476 A1 (Hanshew Dwight D. JR. et al.), 31. May 2007, (2007 May 31) refers to a thyroid hormone (thyroxine) stabilized by a formulation comprising microcrystalline cellulose, mannitol, sucrose and lauryl sulfate as a detergent.
WO 2007/041664 (Allergan, Inc.), 12 Apr. 2007 (2007 Apr. 12), refers to a lyophilized formulation comprising Botulinum toxin, PVP, sucrose or mannitol and Poloxamer 188.
FR 2 881 139 (Agronomique Inst. Nat. Rech.), 28 Jul. 2006 (2006-07-28), refers to formulations comprising in one case protein, mannitol, PVP and TRIS HCI; in another case protein, glycine, PVP and TRIS HCI; and in a third case protein, maltodextrine, saccharose, Polysorbate 80 and TRIS HCI
The present invention, however, refers to certain formulations which result in even more stable formulations rendering them especially suitable when produced under large scale industrial production processes.